A Visual Scale for Improving Communication When Describing Gross Hematuria.
Thomas E Stout, Michael Borofsky, Ayman Soubra
https://pubmed.ncbi.nlm.nih.gov/33285214Actively Recruiting
Phase Not Applicable
MALE
ID06649357
Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study
Led by Fundacio Puigvert · Updated on 2026-04-29
130
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates surgical treatments for benign prostatic hyperplasia (BPH), focusing on comparing two methods: MOSES augmented Holmium Laser Enucleation of the Prostate (MoLEP) and Bipolar Transurethral Resection of the Prostate (Bi-TURP). Both are used to relieve urinary symptoms caused by enlarged prostate, with Bi-TURP often considered the standard. Recent technology upgrades like MOSES 2.0 laser fiber and new morcellators may improve MoLEP outcomes, prompting this study to re-evaluate differences between these two approaches. Participants will be randomly assigned to receive either MoLEP or Bi-TURP surgery performed by experienced surgeons. Both procedures follow standard clinical practice and aim to compare hospital stay length, surgical time, bladder catheter duration, postoperative complications, and functional results. The study will take place across multiple centers and includes follow-up phases extending up to five years. During the study, patients will undergo surgery and regular assessments including urinary symptom evaluations and monitoring for complications over the follow-up periods. Key outcomes measured include hospital stay length from surgery to discharge, total surgical time, and bladder catheterization duration. Data will be collected and analyzed at intervals of six months, two years, and five years to observe both short- and long-term effects and treatment outcomes.
CONDITIONS
Brief Title
Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate
Who Can Participate
MALE
Eligibility Criteria
You may qualify if you...
- Male patients with moderate to severe lower urinary tract symptoms (IPSS score between 8 and 35)
- Prostate volume between 40 and 80 cc measured by ultrasound or MRI
- Maximum urine flow rate less than 15 ml/sec before surgery, or over 15 ml/sec with urodynamic evidence of high-flow obstruction (bladder outlet obstruction index > 40)
You will not qualify if you...
- History of prior prostatic obstructive or urethral surgery
- Diagnosis of prostate or urothelial cancer
- Missing flowmetry or IPSS data before surgery
- Diagnosis or suspicion of hypo/acontractile detrusor
- Diagnosis or suspicion of neurogenic bladder or neurological disease
- History of pelvic radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Surgery conducted between November 2024 and April 2025
Participants undergo surgical treatment for benign prostatic hyperplasia (BPH) using either Moses assisted Holmium Laser Enucleation of the Prostate (MoLEP) or Bipolar Transurethral Resection of the Prostate (BiTURP).
1 surgical procedure visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 1 month post-surgery
Participants receive immediate post-operative care including bladder catheterization and monitoring of hospital stay duration following surgery.
Approximately 6 post-operative visits
Follow-up
Duration - Up to 5 years
Participants are followed up to assess surgical outcomes, complications, urinary symptoms, and functional results over short and long term periods.
Follow-up visits at 6 months, 2 years, and 5 years
Trial Site Locations
Total: 6 locations
1
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15706
Actively Recruiting
2
Fundacio Puigvert
Barcelona, BARCELONA, Spain, 08025
Actively Recruiting
3
Hospital Univesitari de Bellvitge
L'Hospitalet de Llobregat, BARCELONA, Spain, 08907
Not Yet Recruiting
4
Hospital Universitario Marqués de Valdecillas
Santander, Cantabria, Spain, 39008
Actively Recruiting
5
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain, 33394
Actively Recruiting
6
Hospital Universitario Río Hortega
Valladolid, Valladolid, Spain, 47012
Actively Recruiting
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Research Team
I
Ivan Schwartzmann Jochamowitz, MD
S
Silvia Mateu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
Kenneth F Schulz, Douglas G Altman, David Moher...
https://pubmed.ncbi.nlm.nih.gov/20335313Wolf Piranha vs Storz Prostate Morcellation Devices: A Retrospective Multi-Institutional Study.
Katherine Dowd, Hazem ElMansy, Walid Sharour...
https://pubmed.ncbi.nlm.nih.gov/34128395Does MOSES Technology Enhance the Efficiency and Outcomes of Standard Holmium Laser Enucleation of the Prostate? Results of a Systematic Review and Meta-analysis of Comparative Studies.
Vineet Gauhar, Peter Gilling, Giacomo Maria Pirola...
https://pubmed.ncbi.nlm.nih.gov/35105516Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials.
Yucong Zhang, Penghui Yuan, Delin Ma...
https://pubmed.ncbi.nlm.nih.gov/30816336Holmium laser enucleation of the prostate versus open prostatectomy for prostates greater than 100 grams: 5-year follow-up results of a randomised clinical trial.
Rainer M Kuntz, Karin Lehrich, Sascha A Ahyai
https://pubmed.ncbi.nlm.nih.gov/17869409Holmium laser enucleation of the prostate versus open prostatectomy for prostates >70 g: 24-month follow-up.
Richard Naspro, Nazareno Suardi, Andrea Salonia...
https://pubmed.ncbi.nlm.nih.gov/16713070Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms.
Stavros Gravas, Mauro Gacci, Christian Gratzke...
https://pubmed.ncbi.nlm.nih.gov/37202311A New Method of Performing Perineal Prostatectomy.
P J Freyer
https://pubmed.ncbi.nlm.nih.gov/20758920